GIA GIA60MTCRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884521723498), received between Jul 27, 2021 and Aug 12, 2026 — classified as 1 death, 4 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221130 ↗
• MalfunctionAug 12, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221050 ↗
• MalfunctionJul 10, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN GASTRECTOMY PROCEDURE, A STAPLE MALFORMATION WAS OBSERVED WHILE THE DEVICE WAS BEING APPLIED TO THE DUODENUM. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 25781081 ↗
• MalfunctionJun 22, 2026Retraction Problem

  IT WAS REPORTED THAT DURING A BOWEL RESECTION PROCEDURE, DURING AN INTESTINAL ANASTOMOSIS, AFTER FIRING, THE FIVE DEVICES WERE DIFFICULT TO RETRACT THE KNIFE BLADE. THE ISSUE WAS ADDRESSED BY RESECTING AND RE-STAPLING.

  Patient problems: Tissue Breakdown

  MAUDE report 25584155 ↗
• MalfunctionJun 22, 2026Retraction Problem

  IT WAS REPORTED THAT DURING A BOWEL RESECTION PROCEDURE, DURING AN INTESTINAL ANASTOMOSIS, AFTER FIRING, THE FIVE DEVICES WERE DIFFICULT TO RETRACT THE KNIFE BLADE. THE ISSUE WAS ADDRESSED BY RESECTING AND RE-STAPLING.

  Patient problems: Tissue Breakdown

  MAUDE report 25584106 ↗
• MalfunctionJun 22, 2026Retraction Problem

  IT WAS REPORTED THAT DURING A BOWEL RESECTION PROCEDURE, DURING AN INTESTINAL ANASTOMOSIS, AFTER FIRING, THE FIVE DEVICES WERE DIFFICULT TO RETRACT THE KNIFE BLADE. THE ISSUE WAS ADDRESSED BY RESECTING AND RE-STAPLING.

  Patient problems: Tissue Breakdown

  MAUDE report 25583937 ↗
• MalfunctionApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, AFTER USING THE OPEN STAPLER, TOWARDS THE END OF THE PROCEDURE, STAPLES OPENED ON THE GASTROJEJUNOSTOMY OR DUODENOJEJUNOSTOMY ANASTOMOSIS. TO RESOLVE THE ISSUE, RESTAPLING WAS DONE.

  Patient problems: Tissue Breakdown

  MAUDE report 24880335 ↗
• MalfunctionFeb 18, 2026Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FIRING OF THE TWO CARTRIDGES WERE FAULTY. THE DEVICE WAS REPLACED WITH A NEW CARTRIDGE OF THE SAME TYPE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24382898 ↗
• MalfunctionFeb 18, 2026Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FIRING OF THE TWO CARTRIDGES WERE FAULTY. THE DEVICE WAS REPLACED WITH A NEW CARTRIDGE OF THE SAME TYPE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24382707 ↗
• MalfunctionJan 29, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CARTRIDGE DID NOT FIRE. THE DEVICE WAS REPLACED WITH A NEW CARTRIDGE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24217581 ↗
• MalfunctionDec 18, 2025Break; Component or Accessory Incompatibility; Break; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CARTRIDGE BROKE AND COULD NOT BE LOADED. THE DEVICE WAS REPLACED WITH A NEW RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837068 ↗
• MalfunctionOct 22, 2025Material Separation; Material Separation

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE STAPLE BROKE. A NEW CARTRIDGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357370 ↗
• MalfunctionJun 19, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN ILECTOMY, WHEN THE LINEAR STAPLER WAS PLACED ON THE SURGICAL TABLE, THE BLACK INSERT FELL OFF, CAUSING THE BLADE TO SHIFT. ANOTHER STAPLER WAS PLACED ON THE TABLE, AND THE SAME ISSUE OCCURRED. A PURPLE 60-GAUGE REFILL WAS ALSO USED, AND THERE WAS INCOMPLETE STAPLE LINE; ONE END OF THE HANDLE REMAINED OPEN. A MANUAL SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 22293391 ↗
• MalfunctionMar 20, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT, SPECIFICALLY THE CARTRIDGE, BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21650196 ↗
• MalfunctionJan 8, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THERE WERE FIRING ISSUES WITH THE CARTRIDGE GIA60MTC MEDTHK TRISTP, SPECIFICALLY INVOLVING A PARTIAL CUT WITH C OMPLETE STAPLES. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW RELOAD. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21099914 ↗
• MalfunctionNov 21, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A SUBTOTAL GASTRECTOMY AND OPEN COLECTOMY PROCEDURE, AFTER FIRING THE STAPLER, THE CARTRIDGE BROKE. IT WAS THEN REMOVED, WASHED WITH SALINE, AND A SECOND CARTRIDGE WAS THEN SECURELY LOADED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745665 ↗
• DeathApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, AFTER EXTENDED RIGHT HEMICOLECTOMY, ANASTOMOSIS OF THE COLON AND THE ILIUM OPEN PROCEDURE, THE STAPLE LINE WAS VISIBLE AFTER FIRING, AND WHEN POST-OP FOLLOW-UP, THE STAPLE LINE LEAKED. THE PATIENT DIED.

  Patient problems: Tissue Breakdown

  MAUDE report 19179704 ↗
• MalfunctionApr 18, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A ESOPHAGECTOMY, WHEN TRANSECTING, THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED AT ALL, THE DEVICE DID NOT FIRE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19129885 ↗
• MalfunctionJan 11, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN SEGMENTAL RESECTION OF THE SMALL INTESTINE, WHEN CUTTING THE SMALL INTESTINE WITH THE STAPLER, AFTER THE STAPLER WAS FIRED, ONLY ONE SIDE WAS CLOSED WITH THE STAPLES. THE DEVICE WAS FIRED DOWN COMPLETELY, BUT SOME STAPLES WERE MISSING FROM THE STAPLE LINE. IT WAS NOTED THAT IT ALSO HAPPENED ON THE RELOAD UNITS, AND THERE WAS NO CORRECT CLOSURE OF BOTH SIDES WITH STAPLES OR DID NOT FORM PROPER SHAPE. TO RESOLVE THE ISSUE, THE SMALL INTESTINE WAS CLOSED WITH A CLAMP, AND THE DESIRED MANUAL ANASTOMOSIS WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499871 ↗
• MalfunctionJan 11, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN SEGMENTAL RESECTION OF THE SMALL INTESTINE, WHEN CUTTING THE SMALL INTESTINE WITH THE STAPLER, AFTER THE STAPLER WAS FIRED, ONLY ONE SIDE WAS CLOSED WITH THE STAPLES. THE DEVICE WAS FIRED DOWN COMPLETELY, BUT SOME STAPLES WERE MISSING FROM THE STAPLE LINE. IT WAS NOTED THAT IT ALSO HAPPENED ON THE RELOAD UNITS, AND THERE WAS NO CORRECT CLOSURE OF BOTH SIDES WITH STAPLES OR DID NOT FORM PROPER SHAPE. TO RESOLVE THE ISSUE, THE SMALL INTESTINE WAS CLOSED WITH A CLAMP, AND THE DESIRED MANUAL ANASTOMOSIS WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499851 ↗
• MalfunctionOct 20, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN HEMICOLECTOMY PROCEDURE, WHILE ON THE TRANSECTION OF THE COLON, THE STAPLER DID NOT FIRE. ANOTHER CARTRIDGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17977303 ↗
• MalfunctionAug 8, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEMICOLECTOMY PROCEDURE, AT THE COLON, THE SURGEON TRIED THE STAPLER BUT THE STAPLE WAS NOT FIRED PROPERLY, THERE WAS AN INCOMPLETE STAPLE LINE. THE STAPLE LINE WAS OVERSEWN AND THE SURGEON USED ANOTHER RELOAD TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 17484853 ↗
• MalfunctionMar 31, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON AN OPEN GASTRECTOMY, DURING THE TRANSECTION OF THE STOMACH, THE DEVICE DID NOT FIRE. THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED AT ALL. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658798 ↗
• InjuryJan 11, 2023Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF AN OPEN LAPAROTOMY BOWEL RESECTION WHERE THE DEVICE WAS USED FOR RESECTION AND ANASTOMOSIS, THE RESECTED BOWEL STARTED OOZING. THE PATIENT WAS RETURNED TO THEATRE AND THE SURGEON OVER SEWED THE STAPLE LINE WITH SUTURES. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED FOR THREE DAYS.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16137447 ↗
• InjuryJan 10, 2023Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF AN OPEN LAPAROTOMY BOWEL RESECTION WHERE THE DEVICE WAS USED FOR RESECTION AND ANASTOMOSIS, THE RESECTED BOWEL STARTED OOZING. THE PATIENT WAS RETURNED TO THEATRE AND THE SURGEON OVERSEWED THE STAPLE LINE WITH SUTURES. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED FOR THREE DAYS.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16130919 ↗